# K151455: 3Shape Abutment Designer Software

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape A/S
- Decided: Sep 6, 2016 after 463 days
- Product code: PNP (Dental Abutment Design Software For Dental Laboratory)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894844 (1990). 116 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100152: Sirona Cad/Cam System, Sirona Dental Systems GmbH (2010) Summary page 4.

## Most influential descendants
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K200100: Abutment Design (2020), 3 descendants of its own
- K233252: Straumann CARES Visual and Nova Dental CAD (2024), 0 descendants of its own
- K231529: CloudPoint FastDesign Chairside (2024), 0 descendants of its own
- K230873: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (2023), 0 descendants of its own

## Indications for use
The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer Software is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, one-piece, or hybrid dental implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Source page: https://510kreport.com/device/K151455
Methodology: https://510kreport.com/methodology